Label: FLUORIDE- sodium fluoride tablet
- NDC Code(s): 82149-001-01, 82149-001-02
- Packager: Mintly Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 16, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
- Adults and children 2 years of age and older: chew tablet briefly and brush teeth thoroughly, preferably after each meal or at least twice a day or as directed by a dentist or doctor.
- Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
- Supervise children as necessary until capable of using without supervision.
- Children under 2 years of age: Consult a dentist or doctor.
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 240 Tablet Jar Label
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INGREDIENTS AND APPEARANCE
FLUORIDE
sodium fluoride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82149-001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) Sodium Fluoride 0.6552 mg Inactive Ingredients Ingredient Name Strength Microcrystalline Cellulose (UNII: OP1R32D61U) Sodium Bicarbonate (UNII: 8MDF5V39QO) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Sodium Lauroyl Glutamate (UNII: NCX1UU2D33) Magnesium Stearate (UNII: 70097M6I30) Mint (UNII: FV98Z8GITP) MENTHOL, (+)- (UNII: C6B1OE8P3W) Xanthan Gum (UNII: TTV12P4NEE) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) Citric Acid Monohydrate (UNII: 2968PHW8QP) Product Characteristics Color WHITE Score no score Shape ROUND Size 9mm Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82149-001-01 60 in 1 JAR; Type 0: Not a Combination Product 08/30/2021 2 NDC:82149-001-02 240 in 1 JAR; Type 0: Not a Combination Product 08/30/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 08/30/2021 Labeler - Mintly Inc. (118220595)